The FDA released draft guidance last week which should prove helpful to pharmaceutical manufacturers, marketers and communicators. The draft guidance, Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices, addresses questions received by consumers around off-label drug or medical device use. It makes clear that manufacturers are able to provide information to requests on off-label uses, received both on- and off-line, without falling foul of regulations.
The draft guidelines allows for companies to respond to unsolicited requests for information on off-label use that are posted by consumers on public forums – including social media, websites, online forums, and in-person public events and meetings – as well as questions received in a non-public medium – via direct email, letter, phone call or fax. The key is that these must not be solicited questions, defined as any inquiry which results from one of eight possible scenarios or prompts led by the manufacturer.
The FDA advises that any response made to an unsolicited question must a) be made directly to the individual posing the question, and b) must only address the specific questions posed.
This means that even if an individual posts a question on off-label use to a company’s public Facebook wall, the company can only respond directly to that individual (via email, phone or letter) not publically to the post. The most that can be posted publically is information on how an individual can directly contact the company to have their specific question privately addressed.
Responses should, to the greatest extent possible, be made with scientific, fair and balanced, published peer reviewed articles and should come from the company’s scientific or medical personnel, not marketing or sales representatives. Responses must also include approved FDA labeling, a prominent statement indicating that off-label uses are not approved by the FDA, safety warnings and a complete list of scientific references – all elements that fall in-line with current marketing and communications regulations.
While they deem it acceptable to receive questions online, at this time, the FDA cautions against the use of social and digital platforms to publically broadcast off-label use information. The Agency is concerned that any public discussion and response to questions may lead to promotion of off-label uses, may cause confusion among consumers or medical professionals and could generate future problems given the archived nature of outdated information.
These new draft guidelines may not be the comprehensive social and digital media guidance that many, including my colleague, had anticipated, they do provide greater clarity on interaction with consumers through social and digital media channels, specifically around off-label drug use, while also providing some insight into where the Agency may go next with future online guidance.